The production and processing of biocomponents most often requires a sterile environment. To achieve this objective, the systems themselves obviously must be sterilized. Sterilization methods include autoclave, steam-in-place (SIP), gamma irradiation and others. Unfortunately, often, a single sterilization method cannot be used for all components within the system. For example, gamma irradiation is an excellent method of sterilization for certain components, such as disposable bags, tubes, glass, and other similar parts. However, this method is known to be harmful to electronic devices, often destroying the delicate semiconductor structures.
Consequently, it has become necessary to adopt complex procedures to achieve the desired level of system sterilization. It should be noted that sterile, as used in this disclosure, defines a germ free environment. However, sterile does not have to be a complete absence of germs or foreign bodies. Rather, sterile may denote an environment having a predetermined maximum number of germs or foreign bodies. It may also denote an environment with a maximum predetermined size of the germs or foreign bodies found in the environment.
In some cases, these procedures require that the different components be sterilized in the most suitable method available for each. These components are then assembled in a clean room environment. Unfortunately, this adds significant time and cost to the process, especially when considering that many of the components being used are disposable.
United States Patent Publication No. 2007/0185472, assigned to Sartorius, describes a second potential solution to this problem. This application discloses the use of complementary connectors to mate sensors to flow stream components. Displaceable sterile coverings are placed on these complementary connectors. In summary, these coverings ensure that the respective connectors remain sterile. As the connectors are engaged with one another, the coverings slide away, allowing a fluid path between the connectors. In this way, the device attached to the first connector and the device attached to the second connector can be sterilized separately and assembled without the need for a sterile environment.
While this system eliminated the need for a clean room environment, this method still requires separate sterilization procedures for the various system components. A simpler procedure is still necessary.